NCT00682097

Brief Summary

This study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple ascending doses of RO4998452 compared to placebo in patients with type 2 diabetes mellitus. Successive cohorts of patients will be randomized to receive either active drug, at escalating doses, or placebo. The anticipated time on study treatment is \<3 months, and the target sample size is \<100 individuals.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P50-P75 for phase_1 diabetes-mellitus-type-2

Timeline
Completed

Started May 2008

Typical duration for phase_1 diabetes-mellitus-type-2

Geographic Reach
2 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

May 20, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 22, 2008

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

November 2, 2016

Status Verified

November 1, 2016

Enrollment Period

10 months

First QC Date

May 20, 2008

Last Update Submit

November 1, 2016

Conditions

Diabetes Mellitus Type 2

Outcome Measures

Primary Outcomes (2)

  • AEs, laboratory parameters, vital signs.

    Throughout study

  • AUC0-24h, Cmax

    Days 1 and 14

Secondary Outcomes (1)

  • Parameters of glucose metabolism

    Throughout study

Study Arms (7)

1

EXPERIMENTAL
Drug: RO4998452Drug: placebo

2

EXPERIMENTAL
Drug: RO4998452Drug: placebo

3

EXPERIMENTAL
Drug: RO4998452Drug: placebo

4

EXPERIMENTAL
Drug: RO4998452Drug: placebo

5

EXPERIMENTAL
Drug: RO4998452Drug: placebo

6

EXPERIMENTAL
Drug: RO4998452Drug: placebo

7

EXPERIMENTAL
Drug: RO4998452Drug: placebo

Interventions

RO4998452DRUG

Escalating oral doses

1234567
placeboDRUG

Oral doses

1234567

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adult patients, 18-65 years of age;
  • type 2 diabetes;
  • either treated by diet and exercise alone or with metformin.

You may not qualify if:

  • type 1 diabetes mellitus;
  • uncontrolled hypertension;
  • clinically severe diabetic complications.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Unknown Facility

Chula Vista, California, 91911, United States

Location

Unknown Facility

San Antonio, Texas, 78229, United States

Location

Unknown Facility

Neuss, 41460, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2008

First Posted

May 22, 2008

Study Start

May 1, 2008

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

November 2, 2016

Record last verified: 2016-11

Locations

DE(1)US(2)